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Vitamin D AND Glucose Handling Evaluated by Glucose Clamp

NCT ID: NCT00809744

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed.

The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.

Detailed Description

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Conditions

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Insulin Sensitivity Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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cholecalciferol

capsules, 20 000IU, twice a week, 6 months duration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* generally: Subjects are recruited from the 6th Tromsø Study
* cases: serum 25-hydroxyvitamin D-levels below the 10 percentile; low levels confirmed with new serum analyses.
* controls: serum 25-hydroxyvitamin D levels 80-95 percentile, normal-high levels confirmed with new serum analyses.

Exclusion Criteria

* diabetes
* myocardial infarction or apoplexia
* active cancer during last 5 years
* history of kidney stone
* pregnancy or premenopausal without safe anticonception
* primary hyperparathyroidism
* systolic blood pressure \>175 or diastolic blood pressure \>105
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Council on Cardiovascular diseases

UNKNOWN

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical Dpt, University Hospital of Northern Norway

Locations

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University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

References

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Grimnes G, Figenschau Y, Almas B, Jorde R. Vitamin D, insulin secretion, sensitivity, and lipids: results from a case-control study and a randomized controlled trial using hyperglycemic clamp technique. Diabetes. 2011 Nov;60(11):2748-57. doi: 10.2337/db11-0650. Epub 2011 Sep 12.

Reference Type DERIVED
PMID: 21911741 (View on PubMed)

Other Identifiers

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UIT-ENDO-2008-GURI-2

Identifier Type: -

Identifier Source: org_study_id